Cleared Traditional

K872024 - CO2/02 MONITOR MULTINEX

K872024 is an FDA 510(k) clearance for CO2/02 MONITOR MULTINEX, manufactured by Datascope Corp.. The device is a Class 2 Anesthesiology device with product code CCI cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K872024 · Datascope Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
310d
Days
Class 2
Risk

K872024 is an FDA 510(k) clearance for the CO2/02 MONITOR MULTINEX. Classified as Analyzer, Gas, Nitrogen, Gaseous-phase (product code CCI), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1690 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datascope Corp. devices

FDA 510(k) Submission Details - K872024

510(k) Number K872024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date March 31, 1988
Days to Decision 310 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 140d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCI Device Classification - Class 2, Special Controls

Product Code CCI Analyzer, Gas, Nitrogen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.